PSU — Jak2 Gene Mutation Detection Test Class II
FDA product code PSU covers "Jak2 Gene Mutation Detection Test", a Class II medical device regulated under 21 CFR 866.6070. Submissions are reviewed by the Medical Genetics panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PSU
- Device Class
- Class II
- Regulation Number
- 866.6070
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Medical Genetics
- Implant
- No
Definition
The JAK2 gene mutation detection system is a device used to detect mutations and variants in the JAK2 gene. It is intended for use as an adjunct to evaluation of suspected Polycythemia Vera, in conjunction with other clinicopathological factors.